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LBEL

Ventura Corporation Ltd. (San Juan, P.R)

DIVINE LIP GLOSS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Octinoxate 7.5%, Oxybenzone 3.0%.

Purpose

Sunscreen.

LBEL Uses

Helps prevent sunburn.

Warnings

Stop use if skin rash occurs.

Inactive Ingredients

Hydrogenated polyisobutene, diisopropyl dimer dilinoleate, isostearyl neopentanoate, cera alba (beeswax), silica dimethyl silylate, parfum (fragrance), parfum (fragrance), glycerin, prunus amygdalus dulcis oil (prunus amygdalus dulcis (sweet almond) oil), tocopheryl acetate, cocos nucifera oil (cocos nucifera (coconut) oil), aloe barbadensis leaf extract, hydrogenated vegetable oil, propylparaben, methylparaben, sodium saccharin, bht, citrus limon peel cera (citrus limon (lemon) peel wax), citrus limon peel oil (citrus limon (lemon) peel oil), citrus aurantium dulcis peel oil (citrus aurantium dulcis (orange) peel oil), citrus aurantium dulcis peel cera (citrus aurantium dulcis (orange) peel wax). May Contain: CI 77019 (mica), CI 15850 (red 7 lake), CI 77891 (titanium dioxide ), CI 77491, CI 77492, CI 77499 (iron oxides), CI 19140 (yellow 5 lake), CI 16035 (red 40 lake), CI 42090 (blue 1 lake), CI 75470 (carmine), talc, palmitic acid.

Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 12 ml Bottle Carton

DIVINE LIP GLOSS

Lip gloss SPF 15

12 ml e (.40 fl.oz.)

L'BEL

LBEL

LBEL

Octinoxate and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-121
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.075 mL
OXYBENZONE OXYBENZONE 0.03 mL

Inactive Ingredients

Ingredient Name Strength
Diisopropyl Dilinoleate
ISOSTEARYL NEOPENTANOATE
YELLOW WAX
SILICA DIMETHYL SILYLATE
GLYCERIN
ALMOND OIL
ALPHA-TOCOPHEROL ACETATE
COCONUT OIL
Aloe Vera Leaf
PROPYLPARABEN
METHYLPARABEN
saccharin sodium
BUTYLATED HYDROXYTOLUENE
lemon peel wax
LEMON OIL
ORANGE OIL
ORANGE PEEL WAX
MICA
D&C RED NO. 7
titanium dioxide
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
FD&C YELLOW NO. 5
FD&C RED NO. 40
FD&C BLUE NO. 1
ALUMINUM OXIDE
COCHINEAL
talc
PALMITIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-121-01 12 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-11-14


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